|The announcement was made during trading hours today, 11 October 2018.
Meanwhile, the S&P BSE Sensex was down 685.13 points, or 1.97% to 34,075.76
On the BSE, 86,000 shares were traded in the counter so far compared with average daily volumes of 1.89 lakh shares in the past two weeks. The stock had hit a high of Rs 776.50 and a low of Rs 752.90 so far during the day.
Aurobindo Pharma announced that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Azithromycin Oral Suspension 100 mg /5 mL and 200 mg/5 mL. Azithromycin oral suspension, a generic version of Pfizer Inc's Zithromax oral suspension. The product will be launched in November 2018.
Azithromycin oral suspension is indicated for the treatment of patients with mild to moderate infections. The approved product has an estimated market size of US$71 million for the twelve months ending August 2018, according to IQVIA.
This is the 125th ANDA (including 11 tentative approvals) to be approved out of Unit III formulation facility in Hyderabad used for manufacturing oral products. Aurobindo now has a total of 386 ANDA approvals (357 Final approvals including 19 from Aurolife Pharma LLC and 29 tentative approvals) from USFDA.
On a consolidated basis, Aurobindo Pharma's net profit fell 12.12% to Rs 455.66 crore on 15.48% increase in net sales to Rs 4181.56 crore in Q1 June 2018 over Q1 June 2017.
Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company's product portfolio is spread over major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, Anti-Allergies and Anti-Diabetics.
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